VALIDATION QUALITY PLAN



"A validation quality plan must define, detail and mandate means and methods by which an approved change control concept can be progressed through the regulatory qualification process and into cGMP compliant production"


Validation Quality Plan.

The Validation Quality Plan (VQP) is probably the most important of all documents in a validation project.  It is an essential document in giving assurance that the validation task can be successfully executed in an effective, timely and cost effective manner .  Simply because this is the stage in the operation where all aspects of the validation are highlighted, debated, allotted and budgeted for. Once the full scope of the validation task is unearthed; then and then alone, can all these facets be catered for and sensible time lines and responsibilities deliberated.  To this end there may be several VA in any major validation project.  Each VP will cover identical or similar equipment where the validation responsibilities and scopes are identical or similar and can be adequately defined in one validation quality plan.

The top level of the User Requirements Specifications (URS) must be in place to enable the author(s) of the VP to start assessing; not only the basic user level requirements but the attendant needs that the user level requirements make requisite, such as; staff levels, user training, maintenance training, utility and facility loadings.  Along with these requirements will come a multitude of other minor and major issues that only ever become obvious after such extended and invasive studies are completed.  Only when these requirements are fully reviewed and documented, can they be accurately quantified.  However once they are defined, then the VP can start to allocate and document individual staff responsibilities and individual and collective achievable time lines.  Now the stage has arrived where a defined, detailed and workable validation quality plan can be documented, reviewed, and subject to reviewed comments being incorporated; issued by management as the official Validation Quality plan of action.

The VP is the document that the company must use to authorize actual validation methodologies, scopes and associated individual responsibilities (by job title).  It therefore has to work hand in hand with the Validation Risk assessment(VRA).  The VA must list all the equipment that it applies to and the VRA must be executed against each of the items in this list.  On completion of each execution the appropriate scope of validation will be indicated by the VRA.  This scope must be entered into the appropriate section of the VP, before it becomes an approved and locked controlled document.  The VP will therefore list the scope of validation applicable to each listed item along with any individual specific methodologies that should be used.


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Validation Quality Plan Scope.

The Validation Master Plan (VMP) is the single most important document because it describes the basic concept for your overall site validation program. This interactive detailed document is a delight and simple to use.  The generic template and attached SOP lead you through the whole process quickly and seamlessly.  This thirty page document is suitable for all types of pharmaceutical /biotechnical / medical device / API, manufacturer and or processer.  The VMP addresses process validation, facility validation, utility validation, equipment qualification and cleaning validation. The objective is to define responsibilities, outline your methods involved in the qualification and validation of your facility, define the areas and systems to be qualified and validated and to provide a program for achieving and maintaining a validated status.


The VP Role In The Validation Process.

Graphic represents protocolsan validation plans used in full life cycle validation.

Validation Quality Plan Progress.

Graphic portrays the interrelationships between protocolanmd specification used in our validation plan.

VALIDATION QUALITY PLAN.



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SOP for Spreadsheet Creation.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.

SOP for Spreadsheet Creation. -- $125.00

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SOP Equipment Validation.

The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.


Purchase your copy now at Special Price of $22.00.

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Validation Risk Assessment (Issue11.) -- $125.00

The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).

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